Rdi HS CRP Kit
FDA 510(k) K021609 · Reference Diagnostics, Inc.
510(k) numberK021609
Submission
- Device name
- Rdi HS CRP Kit
- Applicant
- Reference Diagnostics, Inc.
Bedford, MA, US - Received
- May 16, 2002
- Decision date
- June 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
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| K053291 | Ferritin Calibrator Set, Catalog No. 8203JIT · Abbreviated | 03/13/2006SE |
| K053211 | Rdi Hsferritin KitDBF · Traditional | 03/13/2006SE |
| K052148 | Total Iron-Binding Capacity Calibrator Set. Direct Tibc Calibrator SetJIT · Abbreviated | 11/09/2005SE |
| K030044 | Extended Range HS CRP Kit, Cat NO:9200DCK · Traditional | 09/30/2003SE |
| K030772 | Rdi Extended Range CRP Calibrator SetJIT · Abbreviated | 04/11/2003SE |
| K021607 | Rdi HS CRP Calibrator SetJIT · Abbreviated | 06/27/2002SE |
| K000783 | Direct Tibc CalibratorJIT · Abbreviated | 05/04/2000SE |
| K000781 | Direct Tibc KitJMO · Traditional | 05/02/2000SE |
| K990216 | Magnetic Tibc KitJMO · Traditional | 02/16/1999SE |
| K984107 | Rdi Direct LDL Cholesterol TestMRR · Traditional | 01/28/1999SE |
Questions and answers
When was Rdi HS CRP Kit cleared by the FDA?
Rdi HS CRP Kit (K021609) received a 510(k) decision of Substantially Equivalent on June 27, 2002, 42 days after the submission was received.
What is the product code of K021609?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.